ACRO Calls on Congress to Require Clinical Testing


John Lewis
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ACRO Calls on Congress to Require Clinical Testing

Date of Release: 14 October 2009

ACRO Calls on Congress to Require Clinical Testing In Biosimilars Legislation to Ensure Patient Welfare, Efficacy

WASHINGTON, D.C., October 14, 2009 –- The Association of Clinical Research Organizations has called on Congress to ensure that any biosimilars legislation it passes requires clinical testing to ensure patient safety, efficacy, purity and potency. ACRO’s recommendations were included in a letter to the congressional committees with jurisdiction over health care policy.

“While much of the debate around biosimilars has centered on the data exclusivity period, our members, as researchers, are more focused on ensuring that the regulatory pathway for approval makes certain that patient welfare is the primary concern and that comparative efficacy is clearly demonstrated,” said Doug Peddicord, Ph.D., Executive Director of ACRO. “The only way to ensure effectiveness and safety for the patient is through rigorous clinical testing, high standards for data quality, and ongoing evaluation.”

Peddicord added that ACRO supports a data exclusivity period of 10-to-12 years for innovators in order to ensure an adequate return on investment, to attract new capital and to encourage continued research and development of breakthrough life-saving and life-enhancing biologics.

About ACRO
The Association of Clinical Research Organizations (ACRO) represents companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 70,000 professionals worldwide and last year conducted more than 9,000 clinical trials involving nearly 2 million participants in 115 countries. For more information, please visit

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